Shanda

EQS-News: Abivax reports 2023 financial results and operational update

Retrieved on: 
Wednesday, April 10, 2024
Q&A, Nomination, New Drug Application, Patient, Shanda, MRO, G&A, IND, EQT, Marketing, Research, EST, McKinsey & Company, Carcinoma, Schering-Plough, Partnership, Webcast, SVP, IBD, Inflammatory Bowel Diseases, American College, Safety, Phase 10, Compensated emancipation, BB Biotech, URD, IPO, F2G, Sofinnova, FDA, AbbVie, EUR, Abstract, Takeda, Pharmaceutical industry

Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.

Key Points: 
  • Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.
  • Cash position (including other financial assets of EUR 9.0M) at the end of 2023 was EUR 261.0M, compared to EUR 27.0M at the end of 2022.
  • A webcast will be organized on Monday, April 8, 2024, at 2:30 p.m. CEST (8:30 a.m. EST) following the announcement of the 2023 yearly results.
  • The Abivax management will give an overview of the Company’s 2023 highlights and projects going forward, followed by a live Q&A session.

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Renal Cancer

Retrieved on: 
Sunday, April 7, 2024
Diagnosis, OS, Nephrectomy, Immunotherapy, DCR, Oncology, Risk, Patient, Shanda, Malignancy, Death, IMDC, Carcinoma, Renal cell carcinoma, Trial of the century, RCC, National Medical Products Administration, ESMO, HKEX, IRC, PFS, Annals of Oncology, Axitinib, Independent Review Committee, Pharmaceutical industry

Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.

Key Points: 
  • Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.
  • There were approximately 77,000 new cases of and 46,000 deaths due to renal carcinoma in China in 2022.
  • Distant metastasis occurred in about one-third of renal carcinoma patients at initial diagnosis, and in 20%-50% of localized patients after nephrectomy.
  • “The approval of toripalimab combined with axitinib addresses the gap in first-line immunotherapy for renal cancer in China.

Abivax reports 2023 financial results and operational update

Retrieved on: 
Tuesday, April 2, 2024
Q&A, Nomination, New Drug Application, Patient, Shanda, MRO, G&A, IND, EQT, Marketing, Research, EST, McKinsey & Company, Carcinoma, Schering-Plough, Partnership, Webcast, SVP, IBD, Inflammatory Bowel Diseases, American College, Safety, Phase 10, Compensated emancipation, BB Biotech, URD, IPO, F2G, Sofinnova, FDA, AbbVie, EUR, Abstract, Takeda, Pharmaceutical industry

Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.

Key Points: 
  • Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.
  • Cash position (including other financial assets of EUR 9.0M) at the end of 2023 was EUR 261.0M, compared to EUR 27.0M at the end of 2022.
  • A webcast will be organized on Monday, April 8, 2024, at 2:30 p.m. CEST (8:30 a.m. EST) following the announcement of the 2023 yearly results.
  • The Abivax management will give an overview of the Company’s 2023 highlights and projects going forward, followed by a live Q&A session.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Vanda Pharmaceutical Inc. - VNDA

Retrieved on: 
Sunday, March 31, 2024
Symantec Endpoint Protection, New Drug Application, Insomnia, Shanda, CRL, Sleep, News, LLP, Pomerantz, FDA, Food

NEW YORK, March 31, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceutical Inc. (“Vanda” or the “Company”) (NASDAQ: VNDA).

Key Points: 
  • NEW YORK, March 31, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceutical Inc. (“Vanda” or the “Company”) (NASDAQ: VNDA).
  • The investigation concerns whether Vanda and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Vanda Pharmaceutical Inc. - VNDA

Retrieved on: 
Saturday, March 23, 2024
Symantec Endpoint Protection, Prior, New Drug Application, Insomnia, Shanda, CRL, Sleep, News, LLP, Pomerantz, FDA, Food

NEW YORK, March 23, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceutical Inc. (“Vanda” or the “Company”) (NASDAQ: VNDA).

Key Points: 
  • NEW YORK, March 23, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceutical Inc. (“Vanda” or the “Company”) (NASDAQ: VNDA).
  • The investigation concerns whether Vanda and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.

Milestone Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Regulatory and Corporate Update

Retrieved on: 
Thursday, March 21, 2024
Research, American Heart Association, Letter, Arrhythmia, Refusal, Offering, Paroxysmal supraventricular tachycardia, Safety, Atrial fibrillation, New Drug Application, Patient, Shanda, NDA, Aes, Science, Net, RTF, Investment, AHA, Milestone, Revera, FDA, Pharmaceutical industry

MONTREAL and CHARLOTTE, N.C., March 21, 2024 (GLOBE NEWSWIRE) --  Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a regulatory and corporate update.

Key Points: 
  • - FDA reiterated prior guidance on regulatory pathway for AFib-RVR, End of Phase 2 Meeting expected mid-2024
    MONTREAL and CHARLOTTE, N.C., March 21, 2024 (GLOBE NEWSWIRE) --  Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a regulatory and corporate update.
  • There was no revenue recorded for the fourth quarter of 2023, compared with $3.5 million the fourth quarter of 2022.
  • Commercial expense for the fourth quarter of 2023 was $5.0 million, compared with $2.6 million for the prior year period.
  • For the fourth quarter of 2023, net loss was $13.6 million, compared to $13.2 million for the prior year period.

Scilex Holding Company Announces a Settlement Agreement with Takeda Pharmaceuticals to Resolve the Paragraph IV Patent Infringement Lawsuit Relating to Scilex’s Filing of a sNDA with the FDA Seeking to Expand the Label for its FDA-Approved Liquid Colchici

Retrieved on: 
Wednesday, March 20, 2024
Paragraph, Gout, Vexatious litigation, Shanda, Chronic pain, Settlement, PALO, Justice, Takeda, License, FDA, Federal Trade Commission, Nursing

That litigation arose from Scilex’s filing of a sNDA with the FDA seeking to expand the label for its FDA-approved liquid colchicine product, Gloperba®, a preventive treatment for gout.

Key Points: 
  • That litigation arose from Scilex’s filing of a sNDA with the FDA seeking to expand the label for its FDA-approved liquid colchicine product, Gloperba®, a preventive treatment for gout.
  • As part of the Settlement Agreement, the Scilex Parties entered into a License Agreement with Takeda granting the Company and its affiliates a non-exclusive license to certain patents owned by Takeda.
  • The Settlement Agreement is subject to approval by the district court, and by both the Federal Trade Commission and the U.S. Department of Justice, as is required in Paragraph IV patent case settlements.
  • For more information on Scilex Holding Company, refer to www.scilexholding.com .

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Vanda Pharmaceuticals Inc. – VNDA

Retrieved on: 
Friday, March 15, 2024
Symantec Endpoint Protection, New Drug Application, Insomnia, Shanda, CRL, Sleep, News, LLP, Pomerantz, FDA, Food

NEW YORK, March 15, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceuticals Inc. (“Vanda” or the “Company”) (NASDAQ: VNDA).

Key Points: 
  • NEW YORK, March 15, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Vanda Pharmaceuticals Inc. (“Vanda” or the “Company”) (NASDAQ: VNDA).
  • The investigation concerns whether Vanda and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.

Zai Lab Partner Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRASG12C-Mutated Locally Advanced or Metastatic...

Retrieved on: 
Monday, April 1, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Lung cancer, BMY, NMPA, Development, NSCLC, Cetuximab, Progression-free survival, New Drug Application, Patient, Neoplasm, Shanda, NDA, Cancer, Bristol Myers Squibb, Pancreatic cancer, CRC, Safety, PFS, FDA, PDUFA, Pharmaceutical industry

The study remains ongoing to assess the additional key secondary endpoint of overall survival.

Key Points: 
  • The study remains ongoing to assess the additional key secondary endpoint of overall survival.
  • Results of the confirmatory trial showed that KRAZATI demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment for these patients.
  • KRAZATI had no new safety signals and the safety data was consistent with the known safety profile.
  • Zai Lab thanks the patients and investigators involved in the KRYSTAL-12 clinical trial.

Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRASG12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung…

Retrieved on: 
Thursday, March 28, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Civil service commission, BMY, NSCLC, Cetuximab, Progression-free survival, Patient, Neoplasm, Shanda, Health care, News, Bristol Myers Squibb, MHRA, Pancreatic cancer, CRC, Safety, European Commission, PFS, PDUFA, Medication, Pharmaceutical industry

The study remains ongoing to assess the additional key secondary endpoint of overall survival.

Key Points: 
  • The study remains ongoing to assess the additional key secondary endpoint of overall survival.
  • Results of the confirmatory trial showed that KRAZATI demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment for these patients.
  • “Today’s news is an important reinforcement of the power of a targeted therapy for patients with locally advanced or metastatic KRASG12C-mutated lung cancer.
  • Bristol Myers Squibb thanks the patients and investigators involved in the KRYSTAL-12 clinical trial.